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Posted: August 7, 2008

FDA remains asleep at the wheel on dangers of sunscreens, besides other cosmetics and personal care products

(Nanowerk News) Following is commentary by Samuel S. Epstein, M.D. Dr. Epstein is Professor Emeritus of Environmental & Occupational Medicine at the University of Illinois at Chicago School of Public Health and Chairman of Cancer Prevention Coalition (http://www.preventcancer.com).

Since 1978, sunscreens have been regulated and labeled by the Food and Drug Administration (FDA) on the basis of their SPF (Skin Protection Factor).

On August 23, 2007, the FDA proposed new regulations for more informative labeling of sunscreens. However, almost a year later, they still remain pending.

In response to FDA's inaction, and mounting concerns on the unreliability of the SPF, Connecticut Attorney General Richard Blumenthal wrote to the FDA on July 24 criticizing its failure to regulate the sunscreen industry, and prevent it from making "dangerously misleading claims" on the safety and effectiveness of its products.

A week later, Senator Jack Reed (D-RI) and Christopher Dodd (D-CT) introduced the "Sunscreen Labeling Act of 2008." This gave the FDA six more months to finalize comprehensive rules, otherwise the Act would become law.

Sunscreens pose scientifically well-documented risks. While well known for over a decade, they remain unregulated by the FDA, and ignored by the industry.

Sunscreens are based on six ingredients, some of which actively penetrate the skin, accumulate in the body, and have been identified in urine and breast milk.

More ominously, these ingredients have toxic hormonal effects, known technically as "endocrine disruptive." Evidence for these effects has been well documented over the last decade. This includes stimulation of human breast cancer cells in test tube experiments, and increased uterine growth in immature female rats following skin painting or feeding.

Sunscreens block short wave ultraviolet light (UVB), which is responsible for sunburn. This encourages prolonged exposure, particularly of children. Moreover, sunscreens are ineffective against long wave ultraviolet light (UVA), which is responsible for malignant melanoma, the fastest growing known cancer. As a result, its incidence has increased by 130 percent, and its mortality has increased by 26 percent since 1975. FDA's continuing regulatory failure in this regard reflects the reckless indifference to consumer product safety of its Commissioner Dr. Andrew von Eschenbach, former director of the National Cancer Institute.

Of major concern, and still ignored by the FDA, is the increasing addition to sunscreens of unlabeled atom or molecule size zinc oxide or titanium dioxide particles. Technically known as nanoparticles, they increase the durability and effectiveness of these products. However, as reported in over two dozen scientific publications since 2003, including those by an Environmental Protection Agency research team and the International Center for Technology Assessment, nanoparticles can penetrate the skin, invade blood vessels, and produce devastating distant toxic effects.

FDA's regulatory failure extends from sunscreens to a wide range of other dangerous ingredients in cosmetics and personal care products. Of illustrative concern is FDA's reckless failure to respond to November 1994 and May 2008 Citizen Petitions, by the Cancer Prevention Coalition, "Seeking a Cancer Warning on Cosmetic Talc Products," used for feminine hygiene. As detailed in these Petitions, talc is a major avoidable cause of ovarian cancer, a relatively rare cancer at any age, whose incidence has escalated dramatically by 12 percent for white and 32 percent for black women, with about 15,000 deaths annually. This makes it the fourth most common fatal cancer after breast, colon and lung.

The "Sunscreen Labeling Act" should be the first step to developing a comprehensive "Cosmetics and Personal Care Products Labeling Act." This could be modeled along the lines of California's precedential 2007 Safe Cosmetics Act.

As warned by Senator Edward Kennedy (D-MA) at September 10, 1997 Hearings on the FDA Reform Bill, "The cosmetics industry has borrowed a page from the playbook of the tobacco industry by putting profits ahead of public health." This warning remains recklessly unheeded by the FDA.